MalfunctionMBP
OSTEOSURGE 300
Received Nov 22, 2016 · Event occurred Sep 29, 2016
Report 6121626 · MDR key 6121626
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
Seaspine Orthopedics CorporationModel number
SSU-16-07241Product problems
- Use of Device Problem
Patient
42 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT WAS IMPLANTED WITH BONE PUTTY THAT THE VENDOR PROVIDED. THE OPERATING ROOM STAFF, NOR THE VENDOR FOLLOW THE TISSUE POLICIES / PROTOCOLS. THERE IS NO STORAGE OR TEMPERATURE DOCUMENTATION RELATED TO THE IMPLANTED BONE PUTTY. THE PATIENT MEDICAL RECORD DOES NOT INDICATE THAT THE BONE PUTTY WAS "TISSUE".